UH3 Project: Pragmatic Trial of Acupuncture for Chronic Low Back Pain in Older Adults (BackInAction)

UH3 Project: Pragmatic Trial of Acupuncture for Chronic Low Back Pain in Older Adults (BackInAction)

Principal Investigators:

Sponsoring Institution: Kaiser Foundation Research Institute, Seattle WA (Performance Site)
Collaborators:

  • Kaiser Permanente Department of Research, Oakland, CA (Performance Site)
  • Sutter Health Research Institute, Palo Alto, CA (Performance Site)
  • Institute of Family Health, New York City, NY (Performance Site)
  • RAND Corporation, Santa Monica, CA

NIH Institute Providing Oversight: National Center for Complementary and Integrative Health (NCCIH)
Program Official: Lanay Mudd, PhD (NCCIH)
Project Scientists: Basil Eldadah, MD, MPH (National Institute on Aging [NIA])

ClinicalTrials.gov Identifier: NCT04982315

Trial Status: Enrolling

Study Snapshot

Trial Summary

A critical gap exists in evidence regarding the safety and effectiveness of treatments for older adults with chronic low back pain (cLBP). Acupuncture has been found to be effective in treating cLBP in younger adults. Yet trials have rarely included older adults, who have more comorbidities and may respond differently than typical trial participants. BackInAction is a pragmatic randomized trial designed to address this gap.

After a planning year to refine strategies to identify and recruit patients, finalize acupuncture protocols with an acupuncture advisory panel, and ensure data infrastructure and quality, the study team will conduct a three-arm trial of 789 adults ≥65 years of age with cLBP to evaluate acupuncture versus usual care. The study will compare a standard 3-month course of acupuncture with an enhanced course of acupuncture (3-month standard course, plus 3-month maintenance course) to usual medical care for cLBP. The primary outcomes of this large trial will be back-related function at 6 months. These and other biopsychosocial measures will be collected at 3, 6, and 12 months post-randomization. The expectation is that back-related function in older adults with cLBP will be most improved among participants in the enhanced acupuncture arm, followed by the standard acupuncture arm, and least improved among those receiving only usual care.

Medicare is also interested in additional data on the value of acupuncture for older adults as they implement their coverage decision. As such, to supplement knowledge gained from the effectiveness trial, the study team may conduct a cost-effectiveness analysis of both forms of acupuncture compared with usual care.

The large study sample will be recruited from four diverse health plans to represent the ethnic and racial composition of Medicare enrollees as well as the most common ways acupuncture is incorporated in insurance-based care for chronic pain. If successful, this pragmatic RCT will offer clear guidance about the value of acupuncture for improving functional status and reducing pain intensity and pain interference for older adults with cLBP. This evidence will provide important information for Medicare about the value of acupuncture in their beneficiaries and for individual physicians and patients deciding on a course of treatment.

NIH Project Information

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Drs. DeBar and Sherman discuss the BackInAction (formerly AcuOA) NIH Collaboratory Trial.

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